When treating an acute myocardial infarction, otherwise known as a heart attack, cardiologists typically install a drug-eluting stent in the blocked artery to open up the vessel and restore blood flow to the heart. However, cardiologists face a difficult decision when choosing the correct size stent. Arteries often appear smaller in diameter upon angiography, due to constricting spasms and blood clots that choke the artery. Choose a stent that is too large, and the artery might rupture. Too small, and the stent will be inadequate when the artery returns to its normal diameter a few days later. Ideally, the stent would be apposed (in contact) with the artery wall at all times. An ill-fitting stent is the primary cause of late-stage thrombosis, a condition in which life-threatening blood clots form in the vessel walls.
Medical device company Stentys seeks to correct the problem of poor apposition with its self-expanding stent technology. Stentys’ product is designed to gently adapt to changes in the artery wall for improved drug release. The stent is also disconnectable, allowing access to both the vessel and large side branches. In September, Stentys announced encouraging results from its Apposition I study, the world’s first study to treat patients with acute myocardial infarction using a self-expanding stent. Blood clots and spasms were resolved after three days, and the Stentys stent remained completely apposed with the vessel throughout the trial.
Stentys announced this week that the first patient has been enrolled in the “Apposition II” clinical study, a randomized trial that will pit the Stentys self-expanding stent against a traditional balloon-expandable stent in patients with acute myocardial infarction. The study will examine stent strut apposition at three days following the installation procedure.
The company estimates the market for its Stentys platform to be approximately $2.5 billion. Stentys intends to simplify the treatment of complex blocked coronary arteries. No training is required for cardiologists to install the company’s “simple stent solutions.” Stentys has headquarters in Princeton, NJ and Paris.
Related video: Gonzague Issenmann, CEO of Stentys